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MX2012000703A - Descontaminacion de superficie de contenedores previamente llenados en empaque secundario. - Google Patents

Descontaminacion de superficie de contenedores previamente llenados en empaque secundario.

Info

Publication number
MX2012000703A
MX2012000703A MX2012000703A MX2012000703A MX2012000703A MX 2012000703 A MX2012000703 A MX 2012000703A MX 2012000703 A MX2012000703 A MX 2012000703A MX 2012000703 A MX2012000703 A MX 2012000703A MX 2012000703 A MX2012000703 A MX 2012000703A
Authority
MX
Mexico
Prior art keywords
prefilled containers
secondary packaging
terminal sterilization
methods
prefilled
Prior art date
Application number
MX2012000703A
Other languages
English (en)
Inventor
Juergen Sigg
Original Assignee
Novartis Ag
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Novartis Ag filed Critical Novartis Ag
Publication of MX2012000703A publication Critical patent/MX2012000703A/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/20Gaseous substances, e.g. vapours
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0082Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using chemical substances
    • A61L2/0094Gaseous substances
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/08Radiation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/08Radiation
    • A61L2/087Particle radiation, e.g. electron-beam, alpha or beta radiation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/20Gaseous substances, e.g. vapours
    • A61L2/208Hydrogen peroxide
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/001Apparatus specially adapted for cleaning or sterilising syringes or needles
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B55/00Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/02Sterilising, e.g. of complete packages
    • B65B55/04Sterilising wrappers or receptacles prior to, or during, packaging
    • B65B55/08Sterilising wrappers or receptacles prior to, or during, packaging by irradiation
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B55/00Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/02Sterilising, e.g. of complete packages
    • B65B55/04Sterilising wrappers or receptacles prior to, or during, packaging
    • B65B55/10Sterilising wrappers or receptacles prior to, or during, packaging by liquids or gases
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10Apparatus features
    • A61L2202/13Biocide decomposition means, e.g. catalysts, sorbents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10Apparatus features
    • A61L2202/14Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20Targets to be treated
    • A61L2202/23Containers, e.g. vials, bottles, syringes, mail

Landscapes

  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Mechanical Engineering (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biomedical Technology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Toxicology (AREA)
  • Molecular Biology (AREA)
  • Medicinal Chemistry (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

Métodos y sistemas para la esterilización terminal y la descontaminación de superficie de los contenedores previamente llenados que contienen productos de fármacos sensibles, tales como los productos de fármacos de biotecnología que de otro modo son sensibles a la temperatura o a la radiación, y de este modo no son convenientes para la esterilización terminal mediante métodos clásicos que involucran vapor o rayos gamma. Los métodos y sistemas son especialmente convenientes para los contenedores previamente llenados en empaques secundarios. Los métodos incluyen la esterilización terminal exponiendo los contenedores previamente llenados en empaque secundario a radiación beta-sintonizable y además incluyen la esterilización terminal exponiendo a los contenedores previamente llenados a peróxido de hidrógeno vaporizado controlable, incluyendo la aplicación de medidas para reducir o prevenir la difusión del peróxido de hidrógeno vaporizado dentro de los contenedores previamente llenados.
MX2012000703A 2009-07-14 2010-07-13 Descontaminacion de superficie de contenedores previamente llenados en empaque secundario. MX2012000703A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP09165456 2009-07-14
PCT/EP2010/060011 WO2011006877A1 (en) 2009-07-14 2010-07-13 Surface decontamination of prefilled containers in secondary packaging

Publications (1)

Publication Number Publication Date
MX2012000703A true MX2012000703A (es) 2012-03-07

Family

ID=41360119

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2012000703A MX2012000703A (es) 2009-07-14 2010-07-13 Descontaminacion de superficie de contenedores previamente llenados en empaque secundario.

Country Status (17)

Country Link
US (1) US20120114524A1 (es)
EP (1) EP2453928A1 (es)
JP (1) JP2012532715A (es)
KR (1) KR20120034103A (es)
CN (1) CN102470185A (es)
AR (1) AR078060A1 (es)
AU (1) AU2010272645B2 (es)
BR (1) BR112012000912A2 (es)
CA (1) CA2767753A1 (es)
CL (1) CL2012000107A1 (es)
CO (1) CO6480986A2 (es)
IL (1) IL216745A0 (es)
MX (1) MX2012000703A (es)
RU (1) RU2012104884A (es)
SG (1) SG176614A1 (es)
TW (1) TW201106993A (es)
WO (1) WO2011006877A1 (es)

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CA3007276C (en) 2015-12-03 2021-12-28 Regeneron Pharmaceuticals, Inc. Use of vegf inhibitor to treat macular degeneration in a patient population
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TW201818910A (zh) 2016-10-21 2018-06-01 美商建南德克公司 無菌密封之異質藥劑遞送裝置
US10806850B2 (en) 2017-02-03 2020-10-20 Bee Sight Limited Medical apparatus and method for sterilizing medical apparatus
IL315639A (en) 2017-03-27 2024-11-01 Regeneron Pharma Sterilization method
CA3030573C (en) * 2017-04-24 2024-06-04 Harpc Solutions Inc. Advanced oxidative process for microbial reduction
EP3630043A1 (en) 2017-05-24 2020-04-08 Formycon AG Sterilizable pre-filled pharmaceutical packages comprising a liquid formulation of a vegf-antagonist
WO2018215580A1 (en) 2017-05-24 2018-11-29 Formycon Ag Method for sterilizing prefilled plastic syringes containing a vegf antagonist
CA3063995A1 (en) 2017-05-24 2018-11-29 Sio2 Medical Products, Inc. Sterilizable pharmaceutical package for ophthalmic formulations
CN111246887B (zh) 2017-10-23 2023-10-03 赢创有限公司 用于聚酯灭菌过程的方法和装置
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US11519020B2 (en) 2018-05-25 2022-12-06 Regeneron Pharmaceuticals, Inc. Methods of associating genetic variants with a clinical outcome in patients suffering from age-related macular degeneration treated with anti-VEGF
US11376194B2 (en) * 2018-09-24 2022-07-05 Oh Pharmaceutical Co., Ltd. Infusion system
EP3721909A1 (en) 2019-04-12 2020-10-14 Grifols Engineering, S.A. Improved device for sterilising flexible bags by electron-beam irradiation and method for sterilising them
CN118718179A (zh) 2019-06-05 2024-10-01 里珍纳龙药品有限公司 用于精确剂量递送的装置及方法
CA3178504A1 (en) 2020-05-21 2021-11-25 Wendy SHIEU Systems and methods for producing sterile injection devices
US20230080971A1 (en) * 2021-09-08 2023-03-16 Regeneron Pharmaceuticals, Inc. Methods for delivering agents with pre-filled syringes to minimize intraocular inflammation
WO2023133064A1 (en) * 2022-01-05 2023-07-13 RexSter Technologies, Inc. X-ray irradiation real time dose measurement/monitoring
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Also Published As

Publication number Publication date
AR078060A1 (es) 2011-10-12
IL216745A0 (en) 2012-02-29
KR20120034103A (ko) 2012-04-09
CO6480986A2 (es) 2012-07-16
JP2012532715A (ja) 2012-12-20
CA2767753A1 (en) 2011-01-20
CL2012000107A1 (es) 2012-09-07
AU2010272645A1 (en) 2012-01-19
US20120114524A1 (en) 2012-05-10
WO2011006877A1 (en) 2011-01-20
CN102470185A (zh) 2012-05-23
RU2012104884A (ru) 2013-08-20
SG176614A1 (en) 2012-02-28
EP2453928A1 (en) 2012-05-23
TW201106993A (en) 2011-03-01
BR112012000912A2 (pt) 2015-09-01
AU2010272645B2 (en) 2013-11-07

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